RICAOS: Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT02494648
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 73
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality (RR = 9.1 [95%, 2.6 to 31.2]).

If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20) appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI> 30) may be too demanding. Alternative treatments are rare and results are highly variable. Therefore, it would be interesting to suggest other treatment modalities with moderate coronary and/or minimally symptomatic OSA syndrome.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive; Acute Coronary Syndrome	Device: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]; Other: Control	N/A

Detailed Description

This study aims to assess the relevance of inspiratory muscles strengthening on reducing AHI in CAD patients with moderate OSA (AHI between 15 and 30).

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)
• Actual Study Start Date: May 22, 2015
• Actual Primary Completion Date: Jun 21, 2021
• Actual Study Completion Date: Jun 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inspiratory muscles strengthening The device used is : POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK). Class I, CE labelled. POWERbreathe fitness Plus uses the technique of training against resistance to increase the strength, the power and the endurance of the respiratory muscles (diaphragm and rib cage).	Device: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]; CAD patients participated in a 6-week (20 sessions of training) resistive inspiratory muscle training (RIMT) program for 10 minutes twice daily at a training intensity of 70% of maximum inspiratory pressure (MIP).
Placebo Comparator: Control No intervention	Other: Control

Outcome Measures

Primary Outcome Measures

1. AHI Variation [At 6 weeks]

   It is the difference between the AHI at the inclusion et the AHI at 6 weeks

Secondary Outcome Measures

1. Circumference of the neck in centimetre [At 6 weeks]

   in centimetre

2. Epworth questionnaire to evaluate the deficit of sleep [at 6 weeks]

   This questionnaire evaluates the deficit of sleep

3. Pittsburgh questionnaire to evaluate the quality of sleep [At 6 weeks]

   This questionnaire evaluates the quality of sleep

4. SF12 questionnaire to evaluate the quality of life [At 6 weeks]

   This questionnaire evaluates the quality of life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with moderate OSA (15 <AHI <30)

• Period between acute coronary syndrome and inclusion <60 days

• Patients included in cardiac rehabilitation

Exclusion Criteria:

• Obstructive lung disease with Tiffeneau index less than 70%.

• Restrictive lung disease with a reduction of total lung capacity (TLC)

• Treatment for OSA or clinical context (comorbidity) justifying CPAP

• Congestive heart failure, thoracic surgery by sternotomy

• Spontaneous pneumothorax

• Severe Asthma

• Ruptured eardrum, or another disease of the middle ear, or acute sinusitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Saint-Etienne	Saint-etienne		France	42000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: David HUPIN, MD, CHU de Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT02494648
• Other Study ID Numbers: 1408189; 2015-A00030-49
• First Posted: Jul 10, 2015
• Last Update Posted: Feb 28, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: Obstructive sleep apnea; Resistive inspiratory muscle training; Coronary artery disease; Cardiac rehabilitation
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Respiratory Aspiration; Sleep Apnea, Obstructive; Acute Coronary Syndrome; Syndrome

Study Results

No Results Posted as of Feb 28, 2022